FDA Adverse Event
Other
Summary report: N
ADVIA CENTAUR CP
MDR report key: 1160503
·
Received September 11, 2008
Report
- Report Number
- 2432235-2008-00103
- Event Type
- Other
- Date Received
- September 11, 2008
- Date of Event
- August 12, 2008
- Report Date
- August 12, 2008
- Manufacturer
- SIEMENS HEALTHCARE DIAGNOSTICS INC.
- Product Code
- MMI
- PMA / PMN Number
- K902336
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
A SIEMENS FIELD SERVICE ENGINEER WAS SENT TO THE SITE. EVALUATION OF THE INSTRUMENT FOUND THAT THE CAUSE OF THE DISCORDANT RESULTS WAS DUE TO LOW WATER VOLUME AND A CROOKED STRAW IN THE WATER BOTTLE. THE WATER BOTTLE WAS REPLACED. THE INSTRUMENT WAS REPAIRED. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.
Description of Event or Problem · 1
POSITIVE ADVIA CENTAUR CP TROPONIN ULTRA RESULTS WERE OBTAINED ON ONE PATIENT SAMPLE. UPON RETEST, THE RESULT WAS NEGATIVE. THE INITIAL RESULTS WERE NOT REPORTED TO THE PHYSICIAN. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TROPONIN ULTRA RESULTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ADVIA CENTAUR CP | IMMUNO-ASSAY ANALYZER | MMI | SIEMENS HEALTHCARE DIAGNOSTICS INC. | N/A | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |